HIV Infections
Conditions
Brief summary
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.
Interventions
DRUGViramune®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffer from HIV type 1 infection * Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors * Patient has shown a depression of viral load before limit of detection (\< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1 * Patient is male or female with age greater than or equal to 18 years * Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation
Exclusion criteria
* Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> five times upper limit of normal (ULN)) * Patients is hypersensitive to Viramune® or to any of its excipients * Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism * Patients is breast-feeding * Patient is pregnant * Patient is a woman and does not use effective contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glucose | Baseline, up to 52 weeks | mg/dl |
| Change in viral load (HIV-RNA) | Baseline, up to 52 weeks | — |
| Change in CD4 cell count | Baseline, up to 52 weeks | — |
| Change in lipid parameters | Baseline, up to 52 weeks | mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of subjective well-being | up to 52 weeks | verbal rating scale |
| Assessment of tolerability by physician and patients | after 52 weeks | verbal rating scale |
| Change in liver enzyme parameter | Baseline, up to 52 weeks | U/l |
| Number of patients with adverse events | up to 52 weeks | — |
Outcome results
None listed